FDA Grants Fast Track Designation to OncoC4's PD-1/VEGF Bispecific Cesalatamig for PD-(L)1-Refractory NSCLC
核心洞察
The FDA has granted Fast Track Designation to OncoC4 (搜索)'s PD-1 (搜索)/VEGF (搜索) bispecific antibody cesalatamig (搜索) for NSCLC that progressed after PD-(L)1 immunotherapy and platinum-based chemotherapy.
Cesalatamig (搜索), also known as AI-081, is being evaluated in global Phase 1/2 BiPAVE-001 trials in the United States and China across more than 50 clinical sites.
OncoC4 (搜索) says the designation reflects clinical safety and efficacy signals from the trials and supports rapid advancement to registrational Phase 3 development in PD-(L)1-refractory or resistant NSCLC.
The U.S. Food and Drug Administration has granted Fast Track Designation to cesalatamig (搜索) (also known as AI-081), OncoC4 (搜索) Inc.'s investigational PD-1 (搜索)/VEGF (搜索) bispecific antibody, for the treatment of patients with non-small cell lung cancer (搜索) (NSCLC) whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.
The designation, announced by the Rockville, Maryland-based company on Sept. 16, 2026, is intended to support expedited development of cesalatamig (搜索) in this PD-(L)1-refractory or resistant NSCLC population.
"This designation reflects the clinical safety and efficacy signals we have seen in our global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4 (搜索). "We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications."
Global Phase 1/2 Program Across More Than 50 Sites
Cesalatamig (搜索) is currently being evaluated in Phase 1/2 studies in the United States (NCT06635785) and in China (CTR20253261). The global BiPAVE-001 trials are designed to assess the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancer.
The program is divided into two parts. Part A is a Phase 1 dose escalation and expansion study. Part B comprises Phase 2 dose optimization studies consisting of multiple cohorts evaluating the safety and clinical activity of cesalatamig (搜索) either as monotherapy or in combination therapy with standard of care or novel agents.
The trials are being conducted at more than 50 clinical sites across the United States and China, with the majority of patients enrolled from the United States.
Differentiated Bispecific Design
According to OncoC4 (搜索), cesalatamig (搜索) is a differentiated PD-1 (搜索)/VEGF (搜索) bispecific antibody with high affinity for PD-1 and more than 40-fold higher affinity for VEGF than bevacizumab-based bispecific PD-(L)1/VEGF inhibitors. The company states that this profile gives cesalatamig best-in-class potential, with a stronger cooperative interaction that favors its action in a PD-1 and VEGF-rich tumor microenvironment.
Cesalatamig (搜索) also carries more effective Fc-silencing modifications intended to avoid depletion of PD-1 (搜索) positive effector T cells.
Broader Pipeline and Collaborations
OncoC4 (搜索) is a privately held, late clinical-stage biopharmaceutical company engaged in the discovery and development of novel biologics for cancer and immunological diseases. Its pipeline includes assets with first-in-class and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases.
Beyond cesalatamig (搜索), which the company describes as wholly owned and undergoing rapid global clinical development in multiple oncology indications, the pipeline includes ONC-841, a first-in-class anti-SIGLEC-10 (搜索) antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases.
OncoC4 (搜索) also has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4 (搜索), in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer (搜索).